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Completed

NCT Number: NCT01100567

Effect Of Biomechanical Stimulation On Skeletal Health In Adolescent And Young Women With Anorexia Nervosa

This study will evaluate the effects of a novel, non-pharmacologic intervention for the prevention of deleterious changes in bone density and strength in adolescents with anorexia nervosa (AN), a disease commonly treated with extended periods of bed rest and immobilization. The primary focus of the trial is to conduct a prospective short-term intervention to prevent an uncoupling of bone turnover in inpatients hospitalized for AN, and to determine the long-term effects of a biomechanical intervention on skeletal health in ambulatory adolescents with AN.

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Malnutrition Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases

Age range

11 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 11-25 years
  • Diagnosis of anorexia nervosa based on DSM-IV criteria
  • Female gender
  • English-speaking

Exclusion criteria

  • • Concomitant chronic diseases which affect bone health, such as cystic fibrosis, inflammatory bowel disease, celiac disease, renal disease, or diabetes mellitus
  • Use of medications known to affect bone metabolism in the last 3 months, such as:
  • Glucocorticoid therapy (including inhaled steroids)
  • Anticonvulsants
  • Combined estrogen/progestin contraceptive agents (oral contraceptive pills)
  • Depot medroxyprogesterone (Depo-Provera) use in the last 12 months
  • Current pregnancy

Treatment and study plan

Low-magnitude mechanical stimulation platform

Device

Low-magnitude mechanical stimulation platform

Primary outcomes

  1. Change From Baseline in C-telopeptides

    Time frame: Baseline to 5 days

Secondary outcomes

  1. Change From Baseline in Bone Specific Alkaline Phosphatase

    Time frame: baseline to 5 days

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Apr 9, 2010
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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